GPO offers to pay over drug mix-up

THE STATE agency that makes medicinal drugs vowed yesterday to take full responsibility and compensate patients affected by an alleged mistake that led to two drugs being put into incorrect packages and sent to state hospitals around the country.

The move follows reports that the Government Pharmaceutical Organisation (GPO) put two wrong medicines in packages with the lot number F561217, and distributed them to seven hospitals. 

Five of the hospitals are reported to have already prescribed the incorrect medicine from the packages to patients.

The seven state hospitals are Makarak in Kanchanaburi, Yang Chum Noi in Si Sa Ket, Phu Kieo in Chaiyaphum, Nong Ya Sai in Suphan Buri, Kok Sam Rong in Lop Buri, Ban Rai in Uthai Thani, and Nakhon Chaisri in Nakhon Pathom.

The medicines – produced on June 19 and distributed to the seven hospitals on July 18 – were Isosorbide dinitrate, used to prevent chest pain caused by coronary artery disease; and Amlodipine, used for high blood pressure treatment. GPO chairman Dr Pipat Yingseri said compensation for patients who were given the wrong drug because of the alleged mistake would be considered on a case by case basis.

“We have to accept the truth that if the patients suffer any complications, the GPO must take responsibility. However, we have to investigate it case by case,” he said at a press conference, adding that he was deeply sorry for the unprecedented incident, which was a big lesson for the GPO to improve its manufacturing process.

GPO has recalled over 400,000 tablets from the hospitals and patients after Makarak Hospital reported on August 30 that Isosorbide dinitrate was put in packages of Amlodipine.

The GPO’s managing director Suvaj Siasiriwattana said there had been no reports of abnormalities taking place with patients yet. He noted that the two drugs should not cause complications for patients with heart disease or high blood pressure, as they were classified in the same medicine group.

He has set up a committee to probe the incident and try to find the cause of the alleged mistake. Results from the inquiry are expected within two weeks. But the preliminary assumption, he said was a mistake in the manufacturing process, as the drugs were being producing at the same time.

However, the Food and Drug Administration (FDA)’s Boonchai Somboonsook said he had ordered the GPO to stop production of these drugs until the GPO improves its manufacturing process and complies with good manufacturing practice (GMP) principles.

Moreover, the GPO must recall all packages of the two medicines from these hospitals within 15 days and submit a report within 30 days to show how it can prevent such a problem recurring.